Fig 1.
NeoSep-SAA test schematic depicting a competitive semi-quantitative immunoassay format.
An elevated presence of SAA in human blood samples prevent test line formation by interacting and consequently inhibiting gold nanoparticle-labelled IgG interaction with recombinant human SAA printed on the nitrocellulose membrane. Test lines appear and are interpreted as follows: POSITIVE (1 line) and POSITIVE (2 lines): inflammatory/infection condition, and NEGATIVE (3 lines): No active inflammation.
Table 1.
Neonatal criteria and neonatal and maternal risk factors used to indicate probable sepsis.
Table 2.
Baseline parameters of the neonatal cohort from NSS (n = 955).
Fig 2.
Flowchart depicting neonatal sample dataset categories as well as the application of inclusion and exclusion criteria on the dataset.
Table 3.
NeoSep-SAA and comparator CRP test performance data from neonatal sepsis study (CCG vs. CNC, n = 714) in terms of sensitivity, specificity, PPV and NPV.
Table 4.
NeoSep-SAA performance data from neonatal sepsis study sub-groups, in terms of sensitivity, specificity, PPV and NPV.
Table 5.
NeoSep-SAA primary performance data from NSS (n = 955).
Comparative NeoSep-SAA and CRP test performance in terms of Sensitivity, Specificity, PPV and NPV in full NSS combined field and hospital cohort.